A number of devices and methods exist for closing skin or tissue having a surgical opening, cut, wound, or dissection, whereby skin or tissue parts separated by the cut are approximated or brought into close proximity forming as narrow gap as possible in the area of the surgical dissection or cut, and then covered by an adhesively attached tape which holds the skin or tissue in closed apposed arrangement until wound healing whereby the tape is removed.
Commercially available DERMABOND® PRINEO® Skin Closure System comprises a mesh having a pressure sensitive adhesive and a polymerization initiator disposed on the mesh. The mesh is applied onto the skin over a wound, and a polymerizable cyanoacrylate based adhesive is then applied on the mesh and bonds the mesh to the skin. However, skin closure systems, such as DERMABOND® PRINEO® Skin Closure System, may benefit from more stretching for flexibility/joint articulation if applied over a joint, such as knee, elbow, or similar, while holding the dissection applied lengthwise or longitudinally along the joint.
A number of attempts to address this issue are known, including commercial products: such as TopClosure® 3S System—Skin Stretching and Secure Wound Closure System; Steri-Strip™ by 3M™; Zip®16 Surgical Skin Closure by Zipline Medical. These known systems are complex and either lack flexibility or lack secure and lasting bonding and coverage which extends for the time needed for full healing, such as 1-2 weeks.
PCT publication No. WO2008/082444 titled “Articles and Methods for Tissue Repair” discloses a method of medically treating a tissue comprising: directing a transfer device to a tissue surface, the transfer device having associated therewith a patterned array of an adhesive; transferring at least a portion of the patterned array of adhesive from the transfer device to the tissue surface by contact adhesion; moving the transfer device away from the tissue surface; positioning an article to be adhered adjacent at least a portion of the adhesive; and adhering the article to the tissue surface using the adhesive.
U.S. Pat. No. 8,353,966 entitled “Scaffold for Bone and Tissue Repair in Mammals” discloses a tissue scaffold for repair and regeneration of bone hard tissue or muscle, skin, or organ soft tissue, the scaffold comprising: a rigid scaffold body having a scaffold central axis, a scaffold transverse dimension, and a scaffold lengthwise dimension which is greater than the scaffold transverse dimension, the scaffold body having a compressive strength between about 20 and about 250 MPa and comprising: biocompatible inorganic glass fibers each having a fiber transverse dimension and a fiber lengthwise dimension which is at least about 10 times the fiber transverse dimension; and an interconnected porosity constituting between about 10 vol. % and about 35 vol. % of the scaffold body; wherein each of the fibers has a diameter between about 20 and about 5000 microns; wherein at least about 75 vol. % of the fibers are longitudinally co-aligned and lie generally lengthwise of the scaffold central axis, are generally free of helical orientation about the scaffold central axis, and are arranged to define open channels within the scaffold which allow fluid flow into and lengthwise within the scaffold; and wherein the fibers are self-bonded together in that adjacent longitudinally aligned fibers are fused together.
U.S. Pat. No. 6,652,559 entitled “Wound Closure System” discloses a wound closure system for closing a wound on a patient, comprising: an elongated flexible backing strip having opposite ends, first and second surfaces facing away from one another and a length and width sufficient to secure facing edges of the wound in close juxtaposition to one another, said backing strip comprising a first portion disposed between said ends and adapted to overlie the facing edges of said wound, and second and third portions disposed on either side of said first portion and each provided with a predetermined number of spaced-apart perforations extending through said backing strip from said first surface to said second surface, said first portion being free of any aperture extending through said backing strip from said first surface to said second surface; a first pressure-sensitive adhesive coated on at least part of the first surface of said backing strip including said second and third portions thereof, to adhere at least said second and third portions of said backing strip to the patient with the facing edges of said wound in said close juxtaposition; a first protective member removably attached to said backing strip and covering said pressure-sensitive adhesive; and a flowable, moisture-curable surgical adhesive for application into said perforations to strengthen the adhesion of said second and third portions of said backing strip to the patient; whereby after (a) removal of said protective member to expose said pressure-sensitive adhesive, (b) application of said backing strip with the exposed pressure-sensitive adhesive onto said patient to secure the facing edges of said wound in said close juxtaposition, and (c) application of said surgical adhesive into said apertures, said surgical adhesive flows through said perforations and upon curing forms discrete bonding sites cooperating with said backing strip to maintain the facing edges of said wound in said close juxtaposition without the cured adhesive adversely affecting the flexibility of said backing strip, wherein a second protective member having a second pressure-sensitive adhesive coated on one side thereof is removably attached to said backing strip and covers said second surface, said strip being disposed between said first and second protective members, and wherein said second protective member is provided with a corresponding number of perforations registering with the perforations defined in said second and third portions of said backing strip, and being in flow communication therewith.
U.S. Pat. No. 6,559,350 entitled “MOISTURE-CURABLE ADHESIVE SUTURE STRIP” discloses a moisture-curable adhesive suture strip for closing a wound on a patient, comprising: an elongated, flexible air-permeable backing member formed of a chemically inert material, and having opposite ends, first and second surfaces facing away from one another and a length and width adapted to secure facing edges of the wound in close juxtaposition to one another, said backing member comprising a first portion disposed between said ends and adapted to overlie the facing edges of said wound, and second and third portions disposed on either side of said first portion; a moisture-curable surgical adhesive on at least part of the first surface of said backing member including said second and third portions thereof, in spaced-apart discrete areas of said first surface; a pressure-sensitive adhesive on the first surface of said backing member between said discrete areas for adhering at least said second and third portions of said backing member to the patient with the facing edges of said wound in said close juxtaposition; and a first removable protective member formed of a chemically inert material releasably secured to said backing member and covering said surgical adhesive and said pressure-sensitive adhesive; whereby after removal of said protective member to expose said surgical adhesive and said pressure sensitive adhesive, and application of said backing member with the exposed surgical adhesive pressure sensitive adhesive onto said patient to secure the facing edges of said wound in said close juxtaposition, said surgical adhesive upon curing forms discrete bonding sites strengthening the adhesion of at least said second and third portions of said backing member to the patient and cooperating with said backing member to maintain the facing edges of said wound in said close juxtaposition without the cured adhesive adversely affecting the flexibility of said backing member.
U.S. Patent Application Publication No. 2013/0012988 entitled “Wound Closure Material” discloses wound closure material with a core of biodegradable material, wherein at least one side of the core of biodegradable material is provided with a multitude of discrete spots of an adhesive and the core of biodegradable material comprises an open cell structure.
U.S. Pat. No. 8,642,831 entitled “Device for Promotion of Hemostasis and/or Wound Healing” discloses a hemostatic matrix material comprising a surface and a plurality of open and interconnected cells, said matrix material comprising gelatine or collagen, wherein the surface of said matrix comprises at least one pharmaceutical composition printed onto said surface in individual and discrete locations, wherein said pharmaceutical composition comprises one or more hemostatic agents.
U.S. Patent Application publication No. 2014/0155916 entitled “Multi-layer Porous Film Material” discloses a surgical implant, comprising: a first porous film layer including a plurality of pores; and a second porous film layer including a plurality of pores, the first and second porous film layers being in a stacked configuration and interconnected to one another at a plurality of attachment points to define at least one void between the first and second porous film layers.
U.S. Patent Application publication No. 2008/0109034 entitled “Controlled Adhesive Locations Facilitating Tissue Remodeling” discloses a surgical implant for adhering two portions of tissue together comprising; a) an implantable matrix having at least one layer and a plurality of openings formed within the at least one layer for tissue growth therethrough; and b) a polymer adhesive about the implantable matrix for adhering the two portions of tissue together, the adhesive polymerizing to adhere the tissue together when the two portions of tissue are brought together.
U.S. Patent Application publication No. 2006/0141012 entitled “Tissue Scaffold” discloses a tissue scaffold comprising: a first film including a plurality of cell openings; and a second film adjacent the first film and including a plurality of cell openings larger than the cell openings of the first film; wherein the cell openings of the first film interconnect with the cell openings of the second film to define pathways extending from the first film to the second film.
U.S. Patent Application publication No. 2013/0204077 entitled “Surgical Scaffolds” discloses a surgical scaffold for soft tissue repair, said surgical scaffold comprising a sheet of non-filamentous polymeric material, at least a portion of the sheet surface comprising a plurality of through-holes.
Leukosan® SkinLink by BSN Medical and distributed by Smith and Nephew Pty Ltd, has an apertured band-aid like structure.
Synthetic tissue adhesive TissuGlu® Surgical Adhesive by Cohera Medical, Inc. is based on a polyurethane prepolymer and is applied in a spot-like discrete application of the adhesive during abdominoplasty, using a multi-point dispenser.
Very flexible and elastic tapes will allow for joint flexibility, but will not hold the skin areas in apposed arrangement due to the same elasticity, potentially resulting in wound dehiscence or surgical complication in which a wound ruptures along a surgical incision. Other known systems fail to fully cover the wound resulting in potential for ingress of contaminants and infection causing microorganisms. Other known systems are overly rigid preventing articulation or bending of the joint.
There continues to be a need for improved devices, systems, and methods for holding skin areas around the dissection in apposed arrangement while still providing for flexibility in longitudinal direction enabling bending of the underlying joints.